Ceevra Receives EU MDR Certification for its Surgical 3D Digital Imaging Platform

Newswise — Newswise – San Francisco, CA (June 5, 2024) – Ceevra, Inc., an advanced surgical visualization company that generates AI-driven patient-specific 3D digital images from standard CT scans and MRIs, has been granted certification as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR). 

Ceevra’s 3D images are used by leading surgeons in multiple specialties for preoperative planning, patient counseling and intraoperative visualization. Ceevra’s 3D images have been the subject of several multisite randomized controlled trials, demonstrating that using Ceevra 3D images leads to improved patient outcomes including reduced operative time, blood loss, patient length-of-stay, and risk of cancer recurrence. Ceevra’s 3D images are generated entirely by Ceevra, requiring no effort from Ceevra’s customers beyond uploading the source CT and MR imaging to Ceevra’s cloud.

EU MDR is the new medical device regulation instituted by the European Commission. Relative to its predecessor, MDR introduces much more stringent requirements for the safety and performance of medical devices, including the requirement for clinical evidence supporting safety and efficacy. “The bar to achieve certification under MDR is extremely high,” said Ken Koster, Ceevra’s chief technology officer. “Our achievement here demonstrates our ability to design and implement high-quality and clinically impactful medical device software.”

Ceevra’s MDR certification permits the company to generate 3D images for any type of procedure in which CT scans or MRIs are used for planning in the European Union. “As in the United States, our initial commercial focus will be on 3D imaging for thoracic, urologic, gynecologic, hepatobiliary, and general surgery procedures,” said Russ Yoshinaka, Ceevra’s chief executive officer. “We’ve already generated a strong body of clinical evidence and US reference customers in kidney and prostate cancer. In lung cancer, the powerful features in our pulmonary 3D images are being used by leading cancer centers in the US, and their European colleagues are further motivated by the 2023 ESTS expert consensus recommendations which highly recommend the use of 3D imaging for all segmentectomy procedures.”

About Ceevra, Inc.

Ceevra is an advanced surgical visualization company using machine learning to transform CTs & MRIs into patient-specific 3D digital models. Ceevra’s 3D models have been used in nearly 3,000 operations by some of the world’s best surgeons to save organs, discharge patients earlier, and reduce risk of cancer recurrence. Ceevra is FDA cleared and CE Marked for all types of surgeries, and in 2023 became the first company cleared by the FDA to use machine learning technology in generating 3D images for urologic and thoracic surgical planning. For more information, visit www.ceevra.com.